Combination Alexandrite Laser and Topical Therapy vs Topical Therapy Alone for Treatment of Melasma
Not Applicable
Completed
- Conditions
- Melasma
- Interventions
- Other: 755nm Alexandrite Laser and Lytera Skin Brightening System (Non-Hydroquinone Topical Therapy)Other: Lytera Skin Brightening System (Non-hydroquinone topical therapy)
- Registration Number
- NCT02095756
- Lead Sponsor
- Cynosure, Inc.
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of a combination of non-hydroquinone topical therapy and a 755nm Alexandrite compared to topical therapy alone for the treatment of facial melasma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- Male or female Subjects aged 18-74 years of age;
- Fitzpatrick Skin Types I-IV;
- Female subjects of childbearing potential must have a negative urine pregnancy test at the beginning of the study, and agree to practice appropriate birth-control to prevent pregnancy during the study. The type and dose of birth control must have been stable for at least 3 months prior to study entry and it is not expected to change during the study; acceptable methods of birth control are oral contraceptives, contraceptive patches/rings/implants Norplant®, Depo-Provera®, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of partner with a documented second acceptable method of birth control should the subject become sexually active.
- Subjects diagnosed with moderate to severe melasma on both sides of the face
- For subjects using medication to treat a concurrent medical condition, type and dose must have been stable for at least 3 months prior to study entry and it is not expected to change during the study (except any medications specifically outlined in the exclusion criteria section)
- Subjects able to avoid prolonged sun exposure on the face for the duration of the study and willing to use appropriate sun avoidance techniques.
- Subjects able to follow study instructions and likely to complete all required visits;
- Subjects/Representative able and willing to sign the Informed Consent (which includes a photography release) prior to any study procedures.
Exclusion Criteria
- Female subjects who are pregnant, nursing or planning a pregnancy during the course of the study;
- Subjects with a condition or who are in a situation which, in the Investigator's opinion, may put the Subject at risk, may confound the study results, or may interfere with the Subject's participation in the study, such as: the use of a concomitant medication that can interfere with the study or worsen any condition when used during the study, the use of medications known to induce photosensitivity;
- Subjects under treatment for a dermatologic condition, which may interfere with the safe evaluation of the study regimen (e.g. eczema, psoriasis, severe sun-damage, dermatitis) and/or have scarring or infection of the area to be treated;
- Subjects with a diagnosis of skin cancer (BCE, SCC, Melanoma, etc.) in the areas to be treated;
- Subject unwilling to avoid any other treatment for melasma during the study (total duration of 30 weeks);
- Subjects with a wash-out period of less than 14 days for melasma treatments at the time of study entry or under current treatment;
- Subjects with prior facial resurfacing, deep or chemical peels within 6 months of the date of study entry;
- Subject unwilling to refrain from any facial cosmetic procedures during the study period (e.g., chemical peels, resurfacing, microdermabrasion, etc.);
- Subject has initiated treatment with hormones including estrogen, progesterone and/or oral contraceptives within 3 months of study entry, or who intend to discontinue hormonal therapy during the study;
- Subject has participated in a clinical research study within the last 30 days prior to enrollment;
- Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or other reasons;
- Subject is unable to meet the study attendance requirements.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 755nm Alexandrite laser Lytera Skin Brightening System (Non-hydroquinone topical therapy) 755nm Alexandrite laser for the treatment of melasma 755nm Alexandrite laser 755nm Alexandrite Laser and Lytera Skin Brightening System (Non-Hydroquinone Topical Therapy) 755nm Alexandrite laser for the treatment of melasma
- Primary Outcome Measures
Name Time Method Melasma clearance up to 3 months post last treatment Evaluate the efficacy of a combination of non-hydroquinone topical therapy and a 755-nm alexandrite laser compared to topical therapy alone in the treatment of melasma .
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
🇺🇸San Diego, California, United States